Background: German authorities reimburse migraine prevention with erenumab only in patients who previously did not have therapeutic success with at least five oral prophylactics or have contraindications to such. In this real-world analysis, we assessed treatment response to erenumab in patients with chronic migraine (CM) who failed five oral prophylactics and, in addition, onabotulinumtoxinA (BoNTA). Methods: We analyzed retrospective data of 139 CM patients with at least one injection of erenumab from two German headache centers. Patients previously did not respond sufficiently or had contraindications to β-blockers, flunarizine, topiramate, amitriptyline, valproate, and BoNTA. Primary endpoint of this analysis was the mean change in monthly headache days from the 4-weeks baseline period over the course of a 12-weeks erenumab therapy. Secondary endpoints were changes in monthly migraine days, days with severe headache, days with acute headache medication, and triptan intake in the treatment period. Results: Erenumab (starting dose 70 mg) led to a reduction of -3.7 (95% CI 2.4-5.1) monthly headache days after the first treatment and -4.7 (95% CI 2.9-6.5) after three treatment cycles (p < 0.001 for both). All secondary endpoint parameters were reduced over time. Half of patients (51.11%) had a >30% reduction of monthly headache days in weeks 9-12. Only 4.3% of the patients terminated erenumab treatment due to side effects. Conclusion: In this treatment-refractory CM population, erenumab showed efficacy in a real-world setting similar to data from clinical trials. Tolerability was good, and no safety issues emerged. Erenumabis is a treatment option for CM patients who failed all first-line preventives in addition to BoNTA.

中文翻译：

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先前未成功通过五项一线口服预防措施和OnabotulinumtoxinA失败的慢性偏头痛患者中的Erenumab：双中心回顾性观察研究。

背景：德国当局仅在以前没有通过至少五种口服预防措施获得治疗成功或没有禁忌症的患者中，才使用艾瑞单抗补偿偏头痛的预防。在此真实世界的分析中，我们评估了对慢性偏头痛（CM）的五种口服预防性治疗失败的人，以及对肉毒杆菌毒素A（BoNTA）无效的患者对erenumab的治疗反应。方法：我们分析了来自德国两个头痛中心的139例CM病人的回顾性数据，这些病人至少注射了一次erenumab。先前患者对β受体阻滞剂，氟尿利嗪，托吡酯，阿米替林，丙戊酸盐和BoNTA的反应不足或禁忌。该分析的主要终点是在12周的erenumab治疗过程中，从4周的基线期开始每月头痛天的平均变化。次要终点是治疗期间每月偏头痛天数，严重头痛天数，急性头痛药物天数和曲坦摄入量的变化。结果：Erenumab（起始剂量70 mg）导致首次治疗后每月头痛减少-3.7（95％CI 2.4-5.1），三个治疗周期后减少-4.7（95％CI 2.9-6.5）（p <0.001对彼此而言）。随着时间的推移，所有次要终点参数均降低。一半的患者（51.11％）在9-12周内每月头痛天数减少了> 30％。由于副作用，只有4.3％的患者终止了erenumab治疗。结论：在这种难治性CM人群中，erenumab在现实环境中显示出与临床试验数据相似的功效。耐受性良好，并且没有出现安全问题。